Phase 1/2 Study to Determine Optimal Dose for Treating Bone Metastases Using Novel STAT-RT Workflow

Status unconfirmed · Not applicable

Conditions studied: Metastatic Bone Lesion

In brief

The purpose of this research study is to evaluate the safety and effectiveness of an experimental procedure called Focused Radiation that may result in a faster way to plan and deliver radiation for the treatment of pain caused by metastatic bone tumors (cancerous tumors that originally came from another organ and have spread to bones). In this trial a single fraction of radiation will be given from 8-15 Gray.

Key facts

Study ID

NCT02145286

Run by

Paul W. Read, MD

People needed

47

Starts

2013-10-01

Expected to finish

2019-01-01

Last updated by the study team

2018-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient has 1-3 major painful osseous metastases (target lesions)
• Radiographic evidence (CT, MR, or PET CT) consistent with osseous metastatic disease on CT, MR, or PET CT obtained within 4 weeks of treatment will be used for pre-study treatment delivery. The GTV of the target lesions will be determined from this radiographic study and must be ≤ 250 cubic centimeters.
• NOTE: Patient is still eligible if a diagnostic image set is not available within 4 weeks of treatment if the patient will undergo a kVCT simulation in the Department of Radiation Oncology with contouring directly onto this image set.
• Patient is medically able to undergo palliative radiation therapy
• Patient has pain that is persistent and distinguishably associated with the target sites to be treated
• Planning Target Volume 1 (PTV1) must be > 5mm from the spinal cord or brain
• Women of Childbearing age and men must consent to use adequate contraception for six months following study entry

You may not qualify if…

• Inability to lie on the treatment table for 1 hour
• Systemic therapeutic radionuclide delivery within 30 days prior to treatment
• Target lesions have been previously treated with external beam radiation
• Long bone target lesions with a Mirels fracture score >7
• Unstable bone in the target lesion requiring surgical stabilization
• PTV1 is located within 5mm of spinal cord or brain
• A serious, uncontrolled medical disorder
• Pregnancy

Where it is running

• University of Virginia Health System — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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